Cardiovascular Effects of Racemic Epinephrine Pellets
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Epinephrine Causing Adverse Effects in Therapeutic Use
In brief
The primary aim of this study was to determine if topical racemic epinephrine pellets affect heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) or mean arterial pressure (MAP) in children receiving dental care under general anesthesia (GA). Thirteen patients requiring prefabricated zirconia crowns on both primary maxillary first molars were recruited into a split-mouth randomized controlled pilot study. Patients received a continuous infusion of propofol and remifentanil with inhaled nitrous oxide/oxygen. After patient randomization and tooth preparation, either saline pellets (control) or racemic epinephrine pellets (treatment) were applied directly to gingival tissue. Vital sign measurements were recorded for 5 minutes. The procedure was repeated with either control or treatment on the contralateral side.
Key facts
- Study ID
- NCT04688346
- Run by
- University of Washington
- People needed
- 13
- Starts
- 2019-06-10
- Expected to finish
- 2019-11-30
- Last updated by the study team
- 2021-05-13
Who can join
Age: 2 and older, up to 9. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Children ages 2-9 years undergoing general anesthesia for comprehensive dental treatment at the University of Washington Center of Pediatric Dentistry.
- Healthy patients according to the American Society of Anesthesiologists (ASA) classification I or II.
- Patients who have caries lesions requiring prefabricated crowns on primary maxillary first molars #B and #I.
You may not qualify if…
- Pediatric patients with any severe systemic illness (ASA Classification III or greater).
- Pediatric patients with known cardiac arrhythmia, cardiovascular disease, diabetes and thyroid disease.
- Patients who are taking anti-arrhythmic, antihypertensive, or ionotropic medications.
- Patients who would need pulpotomy or pulpectomy treatment on primary maxillary first molars #B and I.
Where it is running
- UW Center for Pediatric Dentistry — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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